Preparing for The New EU Medical Device Regulations (MDR): Strategies and Tactics



Overview

The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, 2017. From that date, manufacturers, suppliers, Notified Bodies, and national competent authorities have a transition period of three years to comply with the new set of rules. Given the large scale of changes, there is great pressure on all actors to analyze the MDR, conduct impact assessments, and implement compliant processes. After May 2020, non-compliance threatens CE-mark certification, access to the European market, or, in the case of Notified Bodies, re-designation. We will provide our attendees with an understanding of the Transition Provisions, Re-Certification and Reclassification Components of MDR.

The European Union released the Medical Devices Regulation (MDR 2017/745/EU) to eventually replace the Medical Devices Directive and Active Implantable Medical Devices Directive. The MDR introduces numerous changes, including a shift from the pre-approval stage to more of a life-cycle approach. It also incorporates a variety of European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluations, and Post-Market Clinical Follow-up (PMCF). MDR compliance presents many new challenges to medical device manufacturers.

Why should you attend this seminar?

  • Understand the Medical Device Regulations approach in Europe
  • Understand the structure and purpose of the Medical Device Directives 
  • Explain the use of Essential requirements, including the use of (harmonized) Standards
  • Understand the key changes upcoming in the new EU MDR 
  • Understand the essence of early start in the transition 
  • Understand how to prepare a transition plan
  • Apply the Classification Criteria and Implementation rules
  • Identify the conformity assessment routes 
  • Identify Technical Documentation requirements 
  • Importance and Role of Clinical Data 
  • Identify the importance and contents of Post Market Surveillance
  • Explain and differentiate between the scope of the three EU device directives
Areas Covered in the Session:

  • Introductions and Background
  • The objectives of the MDR
  • Scope & Definitions
  • Placing CE marked product on the market
  • EUDAMED and significance of the European Electronic Database
  • Notified Bodies
  • Classification and Conformity Assessment
  • Clinical Evaluation & Investigations
  • PMS and Vigilance
  • Quality management system requirements in the MDR
  • Device classification and conformity assessment routes changes in the MDR
  • Technical documentation requirements
  • Clinical evaluation process requirements 
  • UDI and traceability requirements 
  • Postmarket surveillance and reporting requirements 
  • Life-cycle review of products linked to risk management and clinical evidence
  • Implications for Notified Bodies, and for organizations working with Notified Bodies
  • Impact on product portfolios and classification
  • The need for improved clinical evidence
  • Strengthening of post market surveillance (PMS)
  • What do our employees need to know about the MDR to maintain compliance?
  • How can we prepare to recertify to the MDR?
  • General obligations of the medical device manufacturer
  • Uploading data and maintaining compliance with EUDAMED
  • UDI in Europe and how it compares with US FDA UDI requirements and traceability of the supply chain
  • Classifying medical devices under the European MDR
  • Conformity assessment procedures and the role of Notified Bodies
Who can Benefit:

  • Class I, II and III/In Vitro Diagnostic medical device manufacturers
  • Contract medical device manufacturers
  • Contract sterilizers
  • Repackagers, relabelers, specification developers, reprocessors of single-use devices
  • Manufacturers of accessories and components sold directly to the end user 
  • U.S. manufacturers of "export only" devices
  • Distributors 
  • Importers
  • User Facilities (e.g., hospitals, nursing homes)

  • Introductions and Background
  • The objectives of the MDR
  • Scope & Definitions
  • Placing CE marked product on the market
  • EUDAMED and significance of the European Electronic Database
  • Notified Bodies
  • Classification and Conformity Assessment
  • Clinical Evaluation & Investigations
  • PMS and Vigilance
  • Quality management system requirements in the MDR
  • Device classification and conformity assessment routes changes in the MDR
  • Technical documentation requirements
  • Clinical evaluation process requirements 
  • UDI and traceability requirements 
  • Postmarket surveillance and reporting requirements 
  • Life-cycle review of products linked to risk management and clinical evidence
  • Implications for Notified Bodies, and for organizations working with Notified Bodies
  • Impact on product portfolios and classification
  • The need for improved clinical evidence
  • Strengthening of post market surveillance (PMS)
  • What do our employees need to know about the MDR to maintain compliance?
  • How can we prepare to recertify to the MDR?
  • General obligations of the medical device manufacturer
  • Uploading data and maintaining compliance with EUDAMED
  • UDI in Europe and how it compares with US FDA UDI requirements and traceability of the supply chain
  • Classifying medical devices under the European MDR
  • Conformity assessment procedures and the role of Notified Bodies
  • Safety and performance requirements
  • Clinical evaluations and "new rules" on adequacy of clinical data and clinical investigations
  • Clinical investigations and Clinical Research Organizations
  • Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
  • Vigilance requirements for Europe
  • Economic operator must verify that a previous economic operator has complied with the EU MDR requirements
  • EU MDR importation and distribution requirements expand regulatory due diligence from legal manufacturer to importers and distributors
  • The role of the Personal Responsible for Regulatory Compliance (PRRC)
  • Planning your transition to the MDR
  • Interactive Discussions
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David R Dills

David R. Dills, Regulatory Affairs & Compliance Consultant is a Keynote Speaker at Compliance Key INC provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 24 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA?s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits. He has been directly involved with constructing, reviewing, and/or remediating regulatory submissions, including 510(k), PMA, IDE applications, BLA and NDA submissions, preparing Supplements, Amendments, and works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.

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Seminar Id:IJ2018S4
image  Speaker: David R Dills
calender   Date: 03/09/2018
clock  Start Time: 6:00 AM PT | 9:00 AM ET
map  Place: Miami, Florida USA
Seminar Fee Includes:
lunch Lunch
tea AM-PM Tea/Coffee
material Seminar Material
hard_copy Hard copy of presentation
certificate Attendance Certificate
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